BN003644 05 de março de 2008 02:00 HORALOCAL
A new Step Forward may Help Increase Appropriate Early use of
Plavix(R) by Simplifying Administration in Acute Coronary Syndrome
Patients
PRINCETON, N.J. and PARIS, March 5 /PRNewswire/ -- Sanofi-aventis
(EURONEXT: SAN and NYSE: SNY) and Bristol-Myers Squibb Company (NYSE:
BMY) announced today that the Committee for Medicinal Products for
Human Use (CHMP) of the European Medicines Evaluation Agency (EMEA)
has issued a positive opinion recommending approval of the 300mg
tablet of the antiplatelet Plavix(R) (clopidogrel bisulfate). This
positive opinion from the CHMP needs to be ratified by the European
Commission in the coming months before final approval.
The new 300mg tablet will facilitate the use of the approved loading
dose of Plavix(R) and the early initiation as recommended by national
and international guidelines in appropriate patients with acute
coronary syndrome (ACS), including those with unstable angina /
non-ST segment elevation myocardial infarction (managed with
percutaneous intervention (PCI) with or without stent or medically
managed) and ST segment elevation myocardial infarction patients. The
300mg tablet is bioequivalent to four 75mg tablets of Plavix(R).
Sanofi-aventis and Bristol-Myers Squibb are committed to further
studying the optimization of the Plavix(R) loading dose in ACS
patients managed with an early invasive strategy in the ongoing large
international clinical trial known as 'CURRENT'. CURRENT is the only
randomized controlled trial designed to investigate in 14,000
patients, whether the use of a clopidogrel 600mg loading dose,
followed by an intensified clopidogrel dosing regimen (6 days at
150mg follow by 75mg) yields improved clinical outcomes as compared to
clopidogrel 300mg loading dose followed by 75mg in ACS patients
managed with an early invasive strategy. The primary endpoint of
CURRENT is the reduction of a composite endpoint of cardiovascular
death, stroke and myocardial infarct (MI) and the results are
expected by the end of 2008.
About Plavix(R)
Plavix(R) is an antiplatelet agent which prevents platelets from
sticking together and forming clots in the arteries and is the only
widely available prescription antiplatelet approved to reduce the
risk of heart attack and stroke across the entire spectrum of ACS.
Plavix(R) is indicated for the reduction of atherothrombotic events
in patients with a history of recent MI, recent stroke or established
peripheral arterial disease (P.A.D.) Plavix(R) is also indicated for
patients with NSTEMI ACS, including those who are to be managed
medically and those managed with PCI (with or without a stent) or
CABG. Additionally Plavix(R) is indicated in STEMI patients.
For ACS patients, European Guidelines (ESC Guidelines for NSTEMI ACS
2007) recommend pre-treatment of unselected patients with Plavix(R)
before angiography results for better outcome of PCI.
The early and long term efficacy and safety profile of Plavix(R) is
well established in clinical trials involving more than 100,000
patients across the full spectrum of ACS, recent MI, recent ischemic
stroke and established P.A.D, with real-world experience since its
launch in more than 70 million patients worldwide.
Plavix(R) is marketed worldwide by sanofi-aventis and Bristol-Myers
Squibb Company as Plavix(R) and Iscover(R).
About sanofi-aventis
Sanofi-aventis, a leading global pharmaceutical company, discovers,
develops and distributes therapeutic solutions to improve the lives
of everyone. Sanofi-aventis is listed in Paris (EURONEXT PARIS: SAN)
and in New York (NYSE: SNY).
About Bristol-Myers Squibb
Bristol-Myers Squibb is a global biopharmaceutical and related health
care products company whose mission is to extend and enhance human
life.
Forward Looking Statements
For sanofi-aventis
This press release contains forward-looking statements as defined in
the Private Securities Litigation Reform Act of 1995, as amended.
Forward-looking statements are statements that are not historical
facts. These statements include product development, product
potential projections and estimates and their underlying assumptions,
statements regarding plans, objectives, intentions and expectations
with respect to future events, operations, products and services, and
statements regarding future performance. Forward-looking statements
are generally identified by the words "expects," "anticipates,"
"believes," "intends," "estimates," "plans" and similar expressions.
Although sanofi-aventis' management believes that the expectations
reflected in such forward-looking statements are reasonable,
investors are cautioned that forward-looking information and
statements are subject to various risks and uncertainties, many of
which are difficult to predict and generally beyond the control of
sanofi-aventis, that could cause actual results and developments to
differ materially from those expressed in, or implied or projected
by, the forward-looking information and statements. These risks and
uncertainties include among other things, the uncertainties inherent
in research and development, future clinical data and analysis,
including post marketing, decisions by regulatory authorities, such
as the FDA or the EMEA, regarding whether and when to approve any
drug, device or biological application that may be filed for any such
product candidates as well as their decisions regarding labeling and
other matters that could affect the availability or commercial
potential of such products candidates, the absence of guarantee that
the products candidates if approved will be commercially successful,
the future approval and commercial success of therapeutic
alternatives as well as those discussed or identified in the public
filings with the SEC and the AMF made by sanofi-aventis, including
those listed under "Risk Factors" and "Cautionary Statement Regarding
Forward-Looking Statements" in sanofi-aventis' annual report on Form
20-F for the year ended December 31, 2006. Other than as required by
applicable law, sanofi-aventis does not undertake any obligation to
update or revise any forward-looking information or statements.
For Bristol-Myers Squibb
This press release contains "forward-looking statements" as that term
is defined in the Private Securities Litigation Reform Act of 1995
regarding product development. Such forward-looking statements are
based on current expectations and involve inherent risks and
uncertainties, including factors that could delay, divert or change
any of them, and could cause actual outcomes and results to differ
materially from current expectations. No forward-looking statement
can be guaranteed. Among other risks, there can be no guarantee that
the European Commission will ratify the CHMP's positive opinion
recommending approval of the 300mg tablet of Plavix(R) or that the
timing of the ratification will occur in Europe as described in this
release. Forward-looking statements in this press release should be
evaluated together with the many risks and uncertainties that affect
Bristol-Myers Squibb's business, including those identified in
Bristol-Myers Squibb's Annual Report on Form 10-K for the year ended
December 31, 2007, particularly under "Item 1A. Risk Factors".
Bristol-Myers Squibb undertakes no obligation to publicly update any
forward-looking statement, whether as a result of new information,
future events or otherwise.
SOURCE Sanofi-aventis and Bristol-Myers Squibb Company
05/03/2008
CONTACT: Sanofi-aventis: MEDIA: Philippe BARQUET,
+33-6-70-48-61-28, philippe.barquet@sanofi-aventis.com; INVESTORS:
Sanjay Gupta, +33-1-53-77-45-45, sanjay.gupta@sanofi-aventis.com;
Bristol-Myers Squibb Company: MEDIA: Ken Dominski, +1-609-252-5251,
ken.dominski@bms.com; INVESTORS: John Elicker, +1-212-546-3775,
john.elicker@bms.com
(SNY BMY)
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